Health Care Week in Review: SAMHSA Releases NSDUH Survey Results, CMS Issues Medicaid Guidance

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, SAMHSA released the results of the 2021 National Survey on Drug Use and Health (NSDUH) and CMS released guidance on how states can address health-related social needs for people with Medicaid coverage. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On December 27, 2022, the Food and Drug Administration (FDA) issued a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device. FDA is classifying the interventional cardiovascular implant simulation software device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the interventional cardiovascular implant simulation software device’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices. This order is effective December 28, 2022.
• On December 28, 2022, FDA issued a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Extracorporeal System for Carbon Dioxide Removal. FDA is classifying the extracorporeal system for carbon dioxide removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal system for carbon dioxide removal’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. This order is effective December 29, 2022.
• On December 29, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF). AHRQ is inviting nominations for individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). Nominated individuals will be selected for the USPSTF on the basis of how well they meet the required qualifications and the current expertise needs of the USPSTF. It is anticipated that new members will be invited to serve on the USPSTF beginning in January 2024. Applications are due by March 15, 2023.
• On December 30, 2022, FDA issued a final order entitled, Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System. FDA is classifying the gastrointestinal lesion software detection system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the gastrointestinal lesion software detection system’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The order is effective January 3, 2023.
• On December 30, 2022, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Safeguarding the Rights of Conscience as Protected by Federal Statutes. HHS is proposing to partially rescind the May 21, 2019, final rule entitled, “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority” (“2019 Final Rule”), while leaving in effect the framework created by the February 23, 2011, final rule, entitled, “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws.” (“2011 Final Rule”). The Department also proposes to retain, with some modifications, certain provisions of the 2019 Final Rule regarding federal conscience protections but eliminate others because they are redundant or confusing, because they undermine the balance Congress struck between safeguarding conscience rights and protecting access to health care access, or because significant questions have been raised as to their legal authorization. Further, HHS seeks to determine what additional regulations, if any, are necessary to implement certain conscience protection laws. HHS is seeking public comment on the proposal to retain certain provisions of the 2019 Final Rule, including on any alternative approaches for ensuring compliance with the conscience protection laws. Comments are due by March 6, 2023.
• On January 3, 2023, the Health Resources and Services Administration (HRSA) issued a request for information (RFI) entitled, Request for Information: Healthy Start Initiative: Eliminating Disparities in Perinatal Health (Healthy Start). HRSA’s Maternal and Child Health Bureau (MCHB), Division of Healthy Start and Perinatal Services (DHSPS) seeks the perspectives of Healthy Start grantees, community members, people with lived experience, health care providers, community health workers, birthing people, parents, and other members of the public to inform future Healthy Start program development.
• On January 5, 2023, FDA issued a final order entitled, Medical Devices; Physical Medicine Devices; Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief. FDA is classifying the virtual reality behavioral therapy device for pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the virtual reality behavioral therapy device for pain relief’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The order is effective January 6, 2023.
• On January 5, 2023, FDA issued a final order entitled, Medical Devices; Physical Medicine Devices; Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser. FDA is classifying the electroencephalography (EEG)-driven upper extremity powered exerciser into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the electroencephalography (EEG)-driven upper extremity powered exerciser’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The order is effective January 6, 2023.
• On January 5, 2023, FDA issued a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate. FDA is classifying the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The order is effective January 6, 2023.

Event Notices

• January 24-25, 2023: HHS announced a public meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). PACCARB will advise and provide information and recommendations to the HHS Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance.
• January 25, 2023: The National Institutes of Health (NIH) announced a public meeting of the National Advisory Dental and Craniofacial Research Council. The meeting agenda will include a discussion of concept clearances and a report from the National Institute of Dental and Craniofacial Research (NIDCR) Director.
• January 30, 2023: NIH announced a public webinar hosted by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) entitled, “Emerging Approaches for Anchoring Biological Relevance of New Approach Methodologies.” The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). This webinar will discuss approaches to build confidence in new approach methodologies (NAMs) that are based on evaluating the biological relevance of the NAM to the species of regulatory interest. Ongoing activities and key insights will be described in three presentations by speakers from the academic and private sector focusing on applications of small model organisms, organs-on-chips, and models of absorption, distribution, metabolism, and excretion.
• January 31, 2023: NIH announced a public meeting of the National Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Advisory Council. The meeting agenda will include a discussion of program policies and issues, as well as the NIAMS Intramural Research Program (IRP) annual report.
• January 31, 2023: NIH announced a public meeting of the National Institute of Nursing Research (NINR) National Advisory Council for Nursing Research (NACNR). The meeting agenda will include a report from the NINR Director, recommendations from working groups, and updates on various NINR research initiatives.
• February 3, 2023: NIH announced a public meeting of the National Eye Institute (NEI) National Advisory Eye Council (NAEC). The meeting agenda will include the presentation of the NEI Director’s report, a discussion of NEI programs, and concept clearances.
• February 8, 2023: NIH announced a public meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). The meeting agenda will include a discussion of National Heart, Lung, and Blood Institute (NHLBI) programs and issues.
• February 9-10, 2023: HHS and the Department of Agriculture (USDA) announced a public meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). HHS and USDA appointed the Committee to conduct an independent scientific review that will help inform the Departments' development of the next edition of the Dietary Guidelines for Americans (Dietary Guidelines). The purpose of this first meeting is to orient the Committee to the Dietary Guidelines process and mark the beginning of its work.
• February 13-14, 2023: NIH announced a public meeting of the National Advisory Council for Human Genome Research (NACHGR). The meeting agenda will include presentations from the National Human Genome Research Institute (NHGRI) Director and from NHGRI staff.
• February 15, 2023: FDA announced a joint public meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The committees will discuss supplemental new drug application 208411/S-006, for NARCAN (naloxone hydrochloride) nasal spray, 4 mg/0.1 mL, submitted by Emergent BioSolutions Inc. NARCAN is proposed for nonprescription treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
• February 17, 2023: NIH announced a public meeting of the NIH Clinical Center Research Hospital Board (CCRHB). The meeting agenda will include NIH and Clinical Center (CC) leadership announcements, an update on recent activities and organizational priorities from the CC CEO, a status report on key CC strategic plan initiatives, and discussion of other business relevant to CCRHB.
• May 16-17, 2023: NIH announced a public meeting of the National Institute on Aging, National Advisory Council on Aging (NIA, NACA). The meeting agenda will include a report from the NIA Director, discussion of future meeting dates and minutes from the last meeting, and an update from the Task Force on Minority Aging Research.
• May 17-18, 2023: NIH announced a public meeting of the National Diabetes and Digestive and Kidney Diseases (NIDDK) Advisory Council. The meeting agenda will include a report from the NIDDK Director and other scientific presentations.
• September 13-14, 2023: NIH announced a public meeting of the NIDDK Advisory Council. The meeting agenda will include a report from the NIDDK Director and other scientific presentations.

II. Reports, Studies & Analyses

• On January 3, 2023, the HHS Office of Inspector General (OIG) published a report entitled, CMS Should Bolster Its Oversight of Manufacturer-Submitted Average Sales Price Data To Ensure Accurate Part B Drug Payments. The Consolidated Appropriations Act, 2021, directed OIG to review manufacturer-reported average sales price (ASP) data. OIG conducted this evaluation to provide insight into the Center for Medicare & Medicaid Services (CMS) oversight of ASP data, including assessing its accuracy before using ASP data to calculate Medicare Part B payment amounts. To determine how CMS oversees the accuracy of manufacturer-submitted ASP data, OIG (1) collected and reviewed CMS’s standard operating procedures for oversight of ASP data; and (2) interviewed CMS staff regarding CMS’s oversight processes and challenges to conducting effective oversight. OIG found that while CMS has some oversight procedures in place to review ASP data (e.g., system edits in the ASP data collection system and CMS’s internal reviews of manufacturer data), gaps exist in its oversight which allowed inaccurate data to effect Medicare Part B payment amounts. OIG recommended that CMS build a strategy to strengthen its internal controls for ensuring the accuracy of Part B drug payments.
• On January 4, 2023, the Congressional Research Service (CRS) published a report entitled, FDA Regulation of Medical Devices. This report describes (1) FDA’s authority to regulate medical devices; (2) medical device classification panels and regulatory classes; (3) device regulatory controls, including general and special controls, as well as premarket approval; (4) special programs to improve access to specific devices; and (5) post-market surveillance systems. The report details the various classification panels and regulatory classes, as well providing an overview of reclassification requests. Finally, CRS also describes a history of laws governing medical device regulation, including the Federal Food, Drug and Cosmetic Act of 1938 (FFDCA), the Safe Medical Devices Act of 1990 (SMDA), and 21st Century Cures Act.
• On January 5, 2023, the Georgetown University Health Policy Institute Center for Children and Families released a report entitled, Consolidated Appropriations Act, 2023: Medicaid and CHIP Provisions Explained. On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes a number of provisions related to Medicaid and the Children’s Health Insurance Program (CHIP).  This includes, among others, delinking the Medicaid continuous coverage requirement from the COVID-19 public health emergency (PHE) and starting its unwinding after March 31, 2023; requiring all states to provide 12 months of continuous eligibility for children in both Medicaid and CHIP; extending federal funding for CHIP for an additional two years; making permanent a state option to provide 12 months postpartum coverage in Medicaid and CHIP; significantly increasing federal Medicaid funding for Puerto Rico and the other territories over the next five years; and instituting several Medicaid and CHIP improvements related to mental health and juvenile justice. The report provides an overview of the various Medicaid and CHIP provisions included in the bill.

III. Other Health Policy News

• On January 4, 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) published the results of the annual National Survey on Drug Use and Health (NSDUH), which contains information about how Americans report on their experience with mental health conditions, substance use, and their pursuit of treatment. Key findings from the 2021 NSDUH include that 25 percent of adults reported living with a mental illness, with that percentage increasing to 33 percent for those aged 18 to 25. Further, 1 in 5 adolescents reported suffering from a major depressive episode in the past year, and 75 percent of these adolescents reported having symptoms consistent with severe impairment that limited their ability to complete daily activities. Among individuals 12 years and older in 2021, 21.9 percent used illicit drugs in the past year, with marijuana being the most commonly used. Additionally, 9.2 million people reporting misusing opioids in 2021. The report also found that 16 percent of the population, more than 46 million individuals, met the criteria for having a substance use disorder (SUD) in the past year. Of those with SUDs, 94 percent reported that they did not receive any treatment for their condition in 2021. The 2021 NSDUH also examined co-occurring SUDs with mental illness and found that 13.5 percent of young adults aged 18 to 25 had both a SUD and a mental illness in the past year. Finally, of those who had ever had a mental illness or a SUD, 66.5 percent and 72.2 percent considered themselves recovering or in recovery respectively. More information on this announcement can be found here.
• On January 4, 2023, CMS sent a letter to state Medicaid Directors in which it outlined guidance to states about how they can utilize the in lieu of services and settings (ILOS) option under Medicaid managed care to address health-related social needs. The ILOS option, available through Medicaid 1115 waivers, allows states to address the social determinants of health (SDOH) through alternative benefits, such as those that provide food and housing security. CMS has already approved ILOS 1115 waivers in Arizona, Arkansas, Massachusetts, and Oregon that address SDOH. The letter reminds states that ILOS programs must be cost effective, medically appropriate, preserve enrollee rights and protections, and fulfill the objectives of the Medicaid program. Overall, while the CMS guidance does not introduce a new Medicaid waiver option, it does provide clarity on how states can utilize the ILOS option through Medicaid. More information on this guidance can be found here.
• On January 5, 2023, CMS issued guidance that aims to create an easier path to specialty care for Medicaid and CHIP beneficiaries. State Medicaid and CHIP programs will be able to pay specialists directly when a beneficiary’s primary health care provider asks for advice. For example, if a pediatrician consults with a specialty behavioral health provider about a specific patient’s needs, both providers may be reimbursed for their care – even if the patient is not present. This move “links” routine care with specialty care, allowing more people to benefit from practitioners with specialized knowledge. The new policy eliminates the need for consulting providers to coordinate payment via separate agreements with the treating practitioner, giving Medicaid and CHIP agencies the flexibility to develop payment methods to reimburse consulting practitioners directly for their services. This new policy aligns Medicaid and CHIP with standards of practice across health care, including in Medicare, which has had a similar policy since 2019. More information on this guidance can be found here.

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